Apparatus to facilitate penetration into a body cavity or lumen formed by body tissue, and method for using same

ABSTRACT

An apparatus to facilitate penetration into a body cavity or lumen formed by body tissue includes a trocar having a shaft, a handle, and a passageway. The shaft has a longitudinal extent with a first end mounted to the handle and a second end having a sharp point. The passageway extends through the shaft and along the longitudinal extent of the shaft from a first opening located near the first end of the shaft to a second opening located near the second end of the shaft.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a non-provisional application based upon U.S. provisional patentapplication Ser. No. 60/766,894, entitled, “DECOMPRESSION ENTEROSTOMYTUBE INSERTION KIT”, filed Feb. 16, 2006.

FIELD OF THE INVENTION

The present invention relates to a surgical device and procedure, and,more particularly, to an apparatus to facilitate penetration into a bodycavity or lumen formed by body tissue, and a method for using theapparatus.

BACKGROUND OF THE INVENTION

A person with a bowel obstruction usually is very sick and comes to anemergency room for admission as a patient to a hospital. Invariably,their abdomen is markedly distended, tender to palpate, and hasdistended loops of small and large bowel, depending upon the site andlevel of bowel obstruction. Nasogastric decompression does help torelieve the gastric distention, but is not effective in relieving thesmall and large bowel distension, which if not treated appropriatelyleads to further complications of perforation, bowel ischemia,septicemia, and other complications.

Such patients with bowel obstructions frequently are sent to theoperating room as an emergency procedure when they are not in the bestof their health, especially when they have multiple other medicalproblems involving multiple organs. These patients usually are very highsurgical and anesthesia risks, and an emergency operation adds to theirstress, making the situation worse.

SUMMARY OF THE INVENTION

The present invention provides apparatus and an associated method tofacilitate penetration into a body cavity or lumen formed by bodytissue, such as for providing drainage of the body cavity, or forproviding decompression of an obstructed lumen of a body part, such as abowel, stomach, or colon, to reduce internal pressure. For example, inthe case of a bowel obstruction, such decompression decreasesintra-abdominal pressure, and thus, for example, improves circulation tothe bowel, relieves ischemia and swelling of the bowel wall, andimproves healing.

The invention, in one form thereof, is directed to an apparatus tofacilitate penetration into a body cavity or lumen formed by bodytissue. The apparatus includes a trocar having a shaft, a handle, and apassageway. The shaft has a longitudinal extent with a first end mountedto the handle and a second end having a sharp point. The passagewayextends through the shaft and along the longitudinal extent of the shaftfrom a first opening located near the first end of the shaft to a secondopening located near the second end of the shaft.

The invention, in another form thereof, is directed to a kit forfacilitating penetration of a body cavity or lumen formed by bodytissue. The kit includes a trocar configured as described above, and acannula having an elongate tube for receiving the shaft of the trocar.

The invention, in another form thereof, is directed to a method forfacilitating drainage of a body cavity or lumen formed by body tissue.The method includes locating a site on a patient for insertion of aprobing apparatus including an assembled trocar and cannula; prepping anarea on the skin around the site with skin prep solution; anaesthetizingthe area around the site; forming an incision in the skin at the site;and inserting the probing apparatus through the incision and into atleast one of the body cavity and the lumen, wherein a portion of thecontents in the body cavity or the lumen is drained through a passagewayformed in the trocar.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of this invention,and the manner of attaining them, will become more apparent and theinvention will be better understood by reference to the followingdescription of embodiments of the invention taken in conjunction withthe accompanying drawings, wherein:

FIG. 1A is a side view of a penetration apparatus configured inaccordance with an embodiment of the present invention.

FIG. 1B is a bottom view of the trocar included in the penetrationapparatus of FIG. 1A.

FIG. 1C is a sectional view of the trocar included in the penetrationapparatus of FIG. 1A taken along line 1C-1C.

FIG. 1D is a sectional view of the trocar included in the penetrationapparatus of FIG. 1A taken along line 1D-1D.

FIG. 1E is a sectional view of an alternative embodiment of the trocarof FIG. 1C.

FIG. 2A is a perspective view, in partial section, of the cannulaincluded in the penetration apparatus of FIG. 1A.

FIG. 2B is a bottom view of the cannula included in the penetrationapparatus of FIG. 1A.

FIG. 3A is a side section view of the assembled trocar and cannula ofFIG. 1A.

FIG. 3B is a bottom view of the assembled trocar and cannula of FIG. 1A.

FIG. 4A is a side view, in partial section, of a catheter used inpracticing a method of the present invention.

FIG. 4B is a bottom view of the catheter of FIG. 4A.

FIGS. 5A and 5B is a flowchart of an exemplary method for decompressinga lumen formed by body tissue, in accordance with an embodiment of thepresent invention.

FIGS. 6-8 are diagrammatic illustrations of implementing the methoddepicted in the flowchart of FIG. 5 in relation to various body tissues.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate embodiments of the invention, and such exemplifications arenot to be construed as limiting the scope of the invention in anymanner.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to the drawings and particularly to FIGS. 1A-3B, there isshown a penetration apparatus 10 configured in accordance with anembodiment of the present invention to facilitate penetration into abody cavity or lumen formed by body tissue. Examples of a body cavityinclude a chest cavity and an abdominal cavity. Examples of a lumenformed by body tissue include a bowel, stomach, or colon. Penetrationapparatus 10 includes a trocar 12, and may further include a cannula 14.Penetration apparatus 10 may be formed from biocompatible materials,such as a plastic.

Trocar 12 has a shaft 16, a handle 18 and a passageway 20. Shaft 16 hasa first end 22 mounted to handle 18 and a second end 24 having a sharppoint 26. Shaft 16 has a longitudinal extent away from handle 18 of alength L1. Referring to FIG. 1C, passageway 20 extends through shaft 16,and along the longitudinal extent of shaft 16, from an opening 28located near first end 22 of shaft 16 to an opening 30 located nearsecond end 24 of shaft 16. In the embodiment shown in FIGS. 1A-1D, forexample, passageway 20 extends through a portion of handle 18 to form adrain port 32 at an outer surface 34 of handle 18.

In the present embodiment, as illustrated in FIGS. 1A and 1D, the lengthL1 of shaft 16 may be, for example, about 16.5 centimeters, andpassageway 20 may have a cross-sectional area A1 of about 3.2 squaremillimeters. Those skilled in the art will recognize, however, thatlength L1 and the cross-sectional area A1 may be determined based on theintended procedure for which penetration apparatus 10 is to be used.

In the present embodiment, opening 30 of passageway 20 is offset from atip 36 of sharp point 26 of shaft 16 that is located at a centerline 38of shaft 16. Second end 24 of shaft 16 has a surface 40 that tapers toform sharp point 26. Surface 40 may define one or more cutting edges 42,which are preferably razor sharp. Opening 30 of passageway 20 is locatedon surface 40, and is spaced away from tip 36 of sharp point 26 of shaft16, and in turn is spaced away from centerline 38 of shaft 16.Alternatively, in another embodiment, opening 30 may be located atcenterline 38 of shaft 16, if desired.

In the present embodiment, a centerline of passageway 20 issubstantially coincident with centerline 38 of shaft 16. However, it iscontemplated that in an alternative embodiment, the centerline ofpassageway 20 and centerline 38 of shaft 16 may be offset, if desired.Also, in the present embodiment, passageway 20 may include a slight bend44, so as to accommodate the location of opening 30 on shaft 16.

FIG. 1E is an alternative embodiment of a trocar 12 a, similar in designto trocar 12 of FIG. 1C, except for having a straight path passageway 20a positioned, for example, along centerline 38 of shaft 16 a forming asharp tip 36 a.

Referring to FIGS. 1A and 2A-3B, cannula 14 is provided to be installedas a sheath over trocar 12. Cannula 14 has an elongate tube 48 forreceiving shaft 16 of trocar 12, and an annular member 50 extendingradially outwardly from elongate tube 48. Elongate tube 48 has a lengthL2, selected such that the length L1 of trocar 12 exceeds length L2 ofelongate tube 48. Length L2 may be, for example, about 15 centimeters.Accordingly, as illustrated in FIGS. 3A and 3B, when shaft 16 of trocar12 is completely inserted into elongate tube 48 of cannula 14, the sharppoint 26 and opening 30 of trocar 12 both project from a distal end 52of elongate tube 48 so as to be exposed. Cannula 14 may further have atleast two axially extending grooves 54, as illustrated in FIGS. 2A and2B, defining a split-line for separating cannula 14 into two parts toease removal of cannula 14 during a procedure.

In the present embodiment, near distal end 52 of cannula 14 there isformed an annular beveled member 56 extending radially outward fromelongate tube 48. Annular beveled member 56 has a tapered leadingsurface 58 to aid in the insertion of cannula 14 through an openingformed in body tissue, e.g., a bowel, and has a blunt trailing surface59 to resist unintended removal of cannula 14 from the opening in thebody tissue, e.g., bowel, in which cannula 14 was inserted.

FIGS. 4A and 4B depict an exemplary balloon catheter 60 that may be usedin association with the present invention. Balloon catheter 60 may beformed from biocompatible materials, such as a plastic. Balloon catheter60 includes a tubular shaft 62 having a drainage port 64 and a flexibleinlet tip end portion 66. A bolster 68 is positioned in a snug slidingfit over tubular shaft 62, and an inflatable balloon 70 is positionedover and is fixedly attached to tubular shaft 62, with balloon 70 beingspaced away from bolster 68 along the length of tubular shaft 62. Aninflation valve 72 is attached to balloon 70 via an inflation tube 74.

Balloon catheter 60 forms a central large bore passage 76 forfacilitating drainage, such as drainage of a body cavity or human lumen,e.g., to aid in decompression of a bowel, or for instillation ofnutrition into the digestive track. Tip end portion 66 is flexible, andis designed to prevent clogging of the central bore passage 76 by havinga plurality of inlet apertures 78. The inflatable balloon 70 and bolster68 cooperate to hold balloon catheter 60 in place, as well as to preventleakage around tubular shaft 62 of balloon catheter 60. For example,bolster 68 acts as a holding guard to secure balloon catheter 60 inplace once bolster 68 is advanced over tubular shaft 62 of ballooncatheter 60 to be snug with the outer layer of the body tissue, and alsoprevents balloon catheter 60 from advancing into the human lumen, e.g.,bowel, or body cavity.

In accordance with the present invention, a kit for facilitatingpenetration of a body cavity or lumen formed by body tissue may include,for example, trocar 12 and cannula 14. The kit may further include, forexample, an assortment of supplies for use with trocar 12 and cannula14, such as sterile drapes and prepping solution. A further addition tothe kit may be, for example, balloon catheter 60.

An exemplary method for decompressing a lumen formed by body tissue, inaccordance with an embodiment of the present invention, will now bedescribed in relation to the flowchart of FIGS. 5A and 5B, and theillustrations of FIGS. 6-8. Those skilled in the art will recognize thatthis method may be easily adapted to provide drainage of a body cavity,e.g., by facilitating insertion of a chest tube.

In FIGS. 6, 7, and 8, there is illustrated various body tissues,including an abdominal wall 80 including skin 82, fat 84, fascia 86,muscle 88, and parietal peritoneum 90. Also shown in FIGS. 6-8 is asection of a bowel 92 having a bowel lumen 94.

At step S100, a site 96 is located for insertion of penetrationapparatus 10. Usually patients with a bowel obstruction, for example,have a distended abdomen which is packed with distended loops of smalland large bowel, depending upon the level of bowel obstruction. The siteof insertion of the penetration apparatus 10 can be easily picked basedon clinical exam, X-ray findings, Ultrasound guidance, or CAT scanguidance. Most of the distended loops of bowel are in close proximity tothe abdominal wall and the area to be decompressed may be selected, mostcommonly in the right abdomen.

At step S102, the area around site 96 is prepped, e.g., at abdominalwall 80, or the area to be drained or decompressed, with skin prepsolution.

At step S104, the area around site 96 is anaesthetized, for example, byinjecting 1% xylocain with 1:100,000, with Epinephrine being preferred.However, any local anesthetic can be used. Thus, the process locallyanaesthetizes the entire thickness of abdominal wall 80, including allthe layers of the abdomen, by injecting the anesthetic in all thelayers.

At step S106, after obtaining adequate local anesthesia, an incision,e.g., one and a half centimeters in length, is made in the skin 82.

At step S108, the assembled trocar 12 and cannula 14 are inserted as aunit (e.g., as penetration apparatus 10) through the incision intoabdominal wall 80, and with a gentle steady pressure applied to handle18 of trocar 12, trocar 12 and cannula 14 are pushed through the entirethickness of abdominal wall 80 till the resistance is not encounteredany more. The razor sharp tip 36 of trocar 12 cuts through the tissueduring penetration, and handle 18 helps to stabilize trocar 12 duringpenetration. Handle 18 on trocar 12 is designed to allow a good grip andfacilitate application of steady pressure during the thrusting of trocar12 through the tissues.

Trocar 12 and cannula 14 will penetrate through the entire thickness ofabdominal wall 80 into the distended bowel 92, and a portion of theintestinal contents in bowel 92 will drain by flowing into opening 30,through passageway 20, and will be expelled out of drain port 32,thereby suggesting that trocar 12 and cannula 14 are into the bowellumen 94. If desired, or necessary, trocar 12 may be installed over aguide wire threaded through passageway 20.

At step S110, cannula 14 is then advanced further into bowel 92 gently,and trocar 12 is removed. At this juncture the intestinal contents inbowel 92 will come out through the cannula 14 freely.

At step S112, referring to FIG. 7, catheter 60 is inserted throughcannula 14 into bowel 92, and balloon 70 on catheter 60 is then gentlyinflated. Caution should be taken to insure that catheter 60 is advancedinto bowel lumen 94 beyond distal end 52 of elongate tube 48 of cannula14 before balloon 70 is insufflated. Catheter 60 is then gently pulledoutwardly away from abdominal wall 80 till balloon 70 is pulling thewall of bowel 92 against the parietal peritoneum 90, thus preventing anyleakage of the intestinal contents in bowel 92 into the peritonealcavity 98, and thus avoiding the contamination of the free peritonealcavity 98. The capacity of balloon 70 is fixed so it does notmechanically obstruct the lumen, especially, for example, when catheter60 is used for feeding rather than for decompression of bowel 92.

At step S114, cannula 14 is removed by splitting cannula 14 into twohalves along groove 54 (see FIGS. 2A and 2B).

At step S116, referring to FIG. 8. the external bolster 68 is gentlyadvanced on tubular shaft 62 of the drainage catheter 60 so that bolster68 is snug against the skin 82 to hold the catheter 60 in place. Silksuture is tied around bolster 68 to prevent any advancement of drainagecatheter 60 into bowel 92.

At step S118, sterile dressing is applied around catheter 60, andcatheter 60 is ready to decompress bowel 92 once attached to any kind ofsuction device. Alternatively, catheter 60 may be left open, e.g.,unattached to a suction device, for gravity drainage. Catheter 60 may beirrigated easily, is desired, to keep catheter 60 patent and properfunctioning.

Advantages of the present invention are numerous, with some being listedbelow by way of example, and not limitation. For example, thedecompression procedure of the present invention is relatively simple toperform and may be accomplished with relative ease, thereby lesseningthe need for a major procedure as an emergency surgery in a sick highrisk surgical patient. The patient may thus be stabilized for definitivecare and treatment after correcting the nutritional status, electrolyteimbalance and prepping the bowel in case it is needed. Also,decompressing the bowel in an obstructed patient will improve therespiratory status by reducing the pressure on the diaphragm, thusimproving ventilation.

Also, a decompressed bowel is easier to manipulate during the surgicalprocedure and will reduce operation time by facilitating fastexploration and quick decision to get to the pathological problem andtake care of it appropriately. The decompression of the distended boweloccurs proximal to the obstruction without major surgical intervention,thus giving an opportunity to the surgeon to plan the electiveprocedure. The procedure may be done at the patient's bed site underlocal anesthesia, and will help to improve the general condition of thepatient by improving nutrition, electrolyte imbalance and help tostabilize the patient before subjecting the patient to a majoroperation.

Examples for use of the present invention include, without limitation:with small bowel obstruction secondary to adhesions, volvulus, internalhernias, tumors, inflammatory bowel disease; with prolonged paralyticileus, prolonged non resolving post operative ileus warrantingdecompression; with colon obstruction secondary to obstruction,volvulus, tumors inflammatory bowel disease, obstipation, neurologicalcauses causing colon distention; to drain localized intraabdominalabscesses without major intervention; facilitating drainage ofintrabbdominal cysts or ascites; facilitating drainage of localizedempyema or hemothorax; open feeding gastrostomy or jejunostomy; and inan insertion of a chest tube.

While this invention has been described with respect to embodiments ofthe invention, the present invention may be further modified within thespirit and scope of this disclosure. This application is thereforeintended to cover any variations, uses, or adaptations of the inventionusing its general principles. Further, this application is intended tocover such departures from the present disclosure as come within knownor customary practice in the art to which this invention pertains andwhich fall within the limits of the appended claims.

1. A apparatus to facilitate penetration into a body cavity or lumenformed by body tissue, comprising a trocar having a shaft, a handle, anda passageway, said shaft having a longitudinal extent with a first endmounted to said handle and a second end having a sharp point, saidpassageway extending through said shaft and along said longitudinalextent of said shaft from a first opening located near said first end ofsaid shaft to a second opening located near said second end of saidshaft.
 2. The apparatus of claim 1, wherein said passageway extendsthrough a portion of said handle to an outer surface of said handle. 3.The apparatus of claim 1, wherein said second opening of said passagewayis offset from a tip of said sharp point of said shaft.
 4. The apparatusof claim 1, wherein said second end of said shaft has a surface thattapers to form said sharp point, said second opening of said passagewaybeing located on said surface and spaced away from a tip of said sharppoint of said shaft.
 5. The apparatus of claim 1, further comprising acannula having an elongate tube for receiving said shaft of said trocar,said shaft of said trocar having a first length and said elongate tubeof said cannula having a second length, said first length exceeding saidsecond length, such that when said shaft of said trocar is completelyinserted into said elongate tube, said sharp point and said secondopening of said trocar project from a distal end of said elongate tubeso as to be exposed.
 6. The apparatus of claim 5, said cannula having anannular beveled member extending radially outwardly from said elongatetube.
 7. The apparatus of claim 5, said cannula having at least twoaxially extending grooves defining a split-line for separating saidcannula into two parts.
 8. A kit for facilitating penetration of a bodycavity or lumen formed by body tissue, comprising: a trocar having ashaft, a handle, and a passageway, said shaft having a longitudinalextent with a first end mounted to said handle and a second end having asharp point, said passageway extending through said shaft and along saidlongitudinal extent of said shaft from a first opening located near saidfirst end of said shaft to a second opening located near said second endof said shaft; and a cannula having an elongate tube for receiving saidshaft of said trocar.
 9. The kit of claim 8, further comprising anassortment of supplies for use with said trocar and said cannula,including sterile drapes and prepping solution.
 10. The kit of claim 8,further comprising a balloon catheter sized for insertion through saidelongate tube.
 11. A method for facilitating drainage of a body cavityor lumen formed by body tissue, comprising: locating a site on a patientfor insertion of a probing apparatus including an assembled trocar andcannula; prepping an area on the skin around said site with skin prepsolution; anaesthetizing said area around said site; forming an incisionin the skin at said site; and inserting said probing apparatus throughsaid incision and into at least one of said body cavity and said lumen,wherein a portion of the contents in said body cavity or said lumen isdrained through a passageway formed in said trocar.
 12. The method ofclaim 11, further comprising: removing said trocar from said cannula;and inserting a catheter in said cannula where said trocar waspreviously located.
 13. The method of claim 12, wherein said catheter isa balloon catheter, said method further comprising: inflating a balloonof said balloon catheter; pulling said catheter outwardly away from saidpatient till said balloon is pulling a wall of one of said body cavityor said lumen to reduce the possibility of leakage of said contentsinternal to said patient; splitting said cannula to aid in removing saidcannula; and advancing an external bolster on a tubular shaft of saidcatheter until said bolster is snug against the skin of said patient.14. The method of claim 13, further comprising applying a vacuum to saidballoon catheter to aid in draining said contents.
 15. The method ofclaim 13, further comprising draining said contents with said ballooncatheter by gravitational force.
 16. The method of claim 13, furthercomprising applying a sterile dressing around said balloon catheter.